FDA approves Chantix warning revisions

Pfizer recently announced a U.S. Food and Drug Administration (FDA) approval of changes to the Chantix label and boxed warning.

The removal of the warning regarding neuropsychiatric events
and updates to the label were based on the Evaluating Adverse Events in a Global
Smoking Cessation Study (EAGLES) smoking cessation clinical trial. This study
evaluated Chantix versus bupropion, a nicotine replacement patch, or a placebo in
patients with and without psychiatric disorders.

Approximately 8,000 smokers
participated in the trial.

“For millions who smoke, stopping smoking is one of the most
important steps they can take to improve their health, and Pfizer is committed
to helping smokers in their quit journey,” Pfizer Inc. Chief Medical Officer Dr. Freda Lewis-Hall said. “We are pleased with the FDA’s decision to
update the Chantix labeling based on EAGLES -- the largest clinical trial of
smoking cessation medications -- and we expect this new information may further
facilitate an informed discussion about quitting with Chantix between smokers
and health care providers.”

Smoking is responsible for approximately 540,000 preventable
deaths in the U.S. annually. Quitting smoking reduces the risk of lung cancer,
heart disease, stroke and other tobacco-related diseases.

“While the benefits of quitting are immediate and
substantial, few smokers are able to quit on their own and need the help of
counseling and smoking cessation therapy,” Massachusetts General Hospital
Center for Addiction Medicine Director Dr. A. Eden Evins said. “As health care providers work on the front
lines to help people who are struggling to quit smoking, this new labeling
provides clinically relevant information on the safety and efficacy of Chantix
to help them and their patients make informed decisions about smoking cessation
treatment.”